Join a diverse number of stakeholders—public health advocates, researchers, manufacturers, lawyers, consumer interests, entrepreneurs, governmental agencies and others—for this two-day conference on effectively regulating the broad spectrum of tobacco and nicotine products in the U.S. and globally. FDA’s Center for Tobacco Products Director, Mitch Zeller will speak about FDA’s July 28th announcement of a comprehensive regulatory plan for tobacco and nicotine regulation and ways the agency will continue to assist industry in complying with federal tobacco regulations.

Register by September 28 and SAVE!

Industry & Firms

$1,299
  • +$500 for non-members
  • +$200 after 9/28/2017

Non-Profit

$799
  • +$100 for non-members
  • +$100 after 9/28/2017

Government

$799
  • +$100 for non-members
  • +$100 after 9/28/2017

Academic

$799
  • +$100 for non-members
  • +$100 after 9/28/2017

Student

$99
  • +$100 for non-members
  • must provide transcripts

Agenda

subject to change

Thursday, October 26

8:15 AM
Registration and Breakfast

9:00–9:05 AM
FDLI Welcome
Amy Comstock Rick
, President & CEO, FDLI

9:05–9:45 AM
Keynote Address
Mitchell R. Zeller
, Director, CTP, Office of Medical Products and Tobacco, FDA

9:45–10:30 AM
Reactor Panel
Panelists will respond to Director Zeller’s comments regarding FDA’s July 28th announcement of FDA’s new plan for tobacco and nicotine regulation; public health challenges related to tobacco use, particularly cigarettes; and limitations under the current Tobacco Control Act.

Brittani Cushman, Vice President of External Affairs, Turning Point Brands, Inc.
David Dobbins, Chief Operating Officer, Truth Initiative
Moderated by Scott Ballin, Tobacco and Health Policy Consultant

10:30–11:00 AM
Coffee and Networking Break

11:00 AM–12:00 PM
Pros and Cons of Very Low Nicotine Cigarettes as a Public Health Strategy

Clive Bates, Director, Counterfactual Consulting Limited
Eric Donny, PhD, Associate Professor of Psychology, University of Pittsburgh
Henry Sicignano, President, CEO & Director, 22nd Century Group, Inc.
Moderated by Raymond Niaura, Professor, Social and Behavioral Sciences, NYU College of Global Public Health, New York University

12:00–1:15 PM
Luncheon with Guest Speaker
Dr. Derek Yach, Founder and President-Designate of the Foundation for a Smoke-Free World

1:15–1:30 PM
Transition

1:30–2:15 PM
PMTA/MRTP Processes, Product Standards, and Other Options
Discussion of how best to regulate tobacco, nicotine, and alternative products using the concept of the continuum of risk. Do these processes stifle or promote innovation and competition and what are the implications for small businesses? Will FDA streamline these processes to better serve both public health needs and the needs of manufacturers?

Bryan M. Haynes, Partner, Troutman Sanders LLP
Patricia Kovacevic,
General Counsel and Chief Compliance Officer, Nicopure Labs LLC and member of the Vapor Technology Association Board
Moderated by James M. Solyst, Vice President, Federal Regulatory Affairs, Swedish Match North America

2:15–3:00 PM
Risk Communications: Getting Truthful Information to the Public, Consumers, and Other Stakeholders
Discussion on how truthful, accurate, and non-misleading information about the risks and relative risks of tobacco, nicotine, and alternative products is transmitted to consumers. What is the role of FDA, other governmental agencies, public health community, and manufacturers?

John Hughes, Professor of Psychology, Psychiatry, University of Vermont
Lynn T. Kozlowski, Professor of Community Health and Health Behavior, University at Buffalo School of Public Health and Health Professions
Donna Vallone, Chief Research Officer, Truth Initiative
Moderated by David Sweanor, Adjunct Professor of Law, University of Ottawa (Invited)

3:00–3:30 PM
Coffee and Networking Break

3:30–4:15 PM
Developing a Multi-Stakeholder Transparent Scientific Research Effort
Discussion on how to improve communications, collaboration, priority setting, and peer review involving a spectrum of stakeholders, which includes trade associations; manufacturers; academic institutions; and FDA and other governmental agencies such as the National Institute of Drug Abuse (NIDA), Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), and U.S. Department of Agriculture (USDA) with a goal of better science to benefit all.

Scott J. Leischow, PhD, Professor, College of Health Solutions, Arizona State University
Chris Proctor, Chief Scientific Officer, Group Research and Development, British American Tobacco (Invited)
Moderated by David Abrams, Professor, Social and Behavioral Sciences, NYU College of Global Public Health, New York University 

4:15–5:00 PM
Substantial Equivalence: Is it in Need of a Tune-up or Modification?
Discussion on determining when and if products are substantially equivalent to existing products on the market. Are the current requirements excessively burdensome? Does FDA have the resources? Can changes be made that will make the process more workable and flexible without compromising public health goals?

Moderated by Stacy Ehrlich, Partner, Kleinfeld, Kaplan & Becker, LLP

5:00–6:30 PM  
Reception

Friday, October 27

8:30–9:00 AM
Breakfast

9:00–10:00 AM 
Where are the Large Domestic and International Tobacco Companies Headed?
Hear from high-level representatives from the tobacco industry who produce cigarettes and a spectrum of reduced risk or next generation products. They will also share their views and perspectives about the future regulatory landscape in the U.S. and globally.

Marc Firestone, Senior Vice President and General Counsel, Philip Morris International, Inc. (Invited)
Ian Jones, Vice President, Reduced-Risk Products, Japan Tobacco International
Jose Murillo, Vice President, Regulatory Affairs, Altria Client Services LLC
Fredrik Peyron, Senior Vice President, Regulatory Affairs and Group Communications, Swedish Match

10:00–10:45 AM 
Multi-Stakeholder Panel
A reactor panel will ask questions, get clarification, and even make suggestions about where they believe the industry should be headed, from their perspectives, and what their responsibilities are.

Greg Conley, President, American Vaping Association

10:45–11:15 AM 
Coffee and Networking Break

11:15 AM–12:15 PM 
The Future of Deeming Regulations: Policy and Litigation  
Panelists will engage in discussions about the future of the Deeming regulations, including issues pertaining to litigation, regulations, legislation, and the pros and cons of extending the implementation dates to 2021 and 2022. Attention will also be given to the appropriate uses of flavorings in both e-cigarettes and cigars and how we can ensure that children and youth are not being encouraged to use such products.

Cynthia Cabrera, President, The Cating Group
David Clissold, Partner, Hyman, Phelps & McNamara, PC
Dennis Henigan, Director, Legal and Regulatory Affairs, Campaign for Tobacco-Free Kids
Kathleen Hoke, Professor & Director, Network for Public Health Policy, University of Maryland Law School
Moderated by Azim Chowdhury, Partner, Keller and Heckman LLP

12:15–1:15 PM
Luncheon and Facilitated Table Topic Discussions

1:15–1:30 PM 
Transition

1:30–2:30 PM 
Building Better Relationships with FDA and between Stakeholders
How are relationships with FDA working and how they might be improved? How does FDA’s new vision impact such relationships? What are opportunities for ongoing engagement and dialogue in both the public and private sectors to public health, allowing manufacturers and other stakeholders to participate in the process?

Moderated by Dean Cirotta, President & CEO, EAS Consulting Group, LLC (Invited)

2:30–3:30 PM 
How Might Lessons Learned from the U.S. Inform Regulatory Development in Other Countries?
Given that issues related to tobacco, nicotine, and alternative products regulation are global in scope, panelists will discuss how U.S. policy might serve as a roadmap for both developed and developing countries and challenges in using the U.S. as a roadmap.

3:30 PM
Conference Adjournment

Planning Committee

Azim Chowdhury, Partner, Keller and Heckman LLP
Dean R. Cirotta, President & CEO, EAS Consulting Group, LLC
Stacy L. Ehrlich, Partner, Kleinfeld, Kaplan & Becker, LLP
Gal Cohen, Head of Scientific and Regulatory Affairs, Pax Labs, Inc.
Stacey Gagosian, Managing Director of Public Policy, Truth Initiative
Joseph Graham Gitchell, President, Pinney Associates, Inc.
Jonathan A. Havens, Associate, Saul Ewing LLP
Bryan M. Haynes, Partner, Troutman Sanders LLP
Dennis Henigan, Director, Legal and Regulatory Affairs, Campaign for Tobacco-Free Kids
Ondrej Koumal, Director Reduced Risk Products, Corporate Affairs, PMI Global Services Inc.
Marina A. Murphy, British American Tobacco
May D. Nelson, Deputy Director, Office of Regulations, Center for Tobacco Products, FDA
James M. Solyst, Vice President, Federal Regulatory Affairs, Swedish Match North America
Elizabeth Oestreich, Vice President, Regulatory Compliance, Greenleaf Health LLC
Jim Swauger, Independent Consultant

Continuing Legal Education

FDLI applies for CLE credits in Ohio, Pennsylvania, and Virginia. These CLE approvals may also be honored by other states; please check with your bar association for guidance. The CLE credits will be posted as they are granted and you can request to be notified when approval is received.

Location and Overnight Accommodations

Conference Location

W Washington DC
515 15th Street NW
Washington, DC 20004

Overnight Accommodations

Rooms are available at a discounted rate of $379 a night through September 28. Online registration is required to qualify for the discounted rate. After that date, rates, and availability may vary.

Reserve Your Room

Driving, Parking, and Public Transportation

Driving, Parking, and Public Transportation

Please contact the Conference Department with any accessibility requirements or dietary restrictions, or for other questions.